Back to resultsSpastic Cerebral Palsy and Slackline (SCPSLACK)
Primary Purpose
Spastic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification.
- Between 9 and 16 years of age.
- Ability to cooperate with simple instructions.
- Able to stand for at least 2 min without assistance.
- Able to walk at least 10 m without assistance.
Exclusion Criteria:
- Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising
- or if they did not meet the eligibility criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supervised Slackline Training
Physical Activity
Arm Description
Supervised Slackline training in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System). Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.
The control group followed its usual weekly physical activity routine.
Outcomes
Primary Outcome Measures
Static posturography (a composite measure).
The centre of pressure (CoP) parameters (these CoP parameters; Length, Xmean, Ymean, Xdeviation and Ydeviation in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography).
Secondary Outcome Measures
Myoelectrical activity.
Soles, Tibialis Anterior and Peroneus Longus (myoelectrical activity in microvolts).
Jump Performance
Countermovement Jump Test and Abalakov´s Test (jump height in cm).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03486483
Brief Title
Spastic Cerebral Palsy and Slackline
Acronym
SCPSLACK
Official Title
The Slackline as a Rehabilitation Tool for Children and Teenagers With Spastic Cerebral Palsy: a Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
April 1, 2015 (Actual)
Study Completion Date
May 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis Santos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised Slackline Training
Arm Type
Experimental
Arm Description
Supervised Slackline training in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System). Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.
Arm Title
Physical Activity
Arm Type
No Intervention
Arm Description
The control group followed its usual weekly physical activity routine.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.
Primary Outcome Measure Information:
Title
Static posturography (a composite measure).
Description
The centre of pressure (CoP) parameters (these CoP parameters; Length, Xmean, Ymean, Xdeviation and Ydeviation in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography).
Time Frame
6 weeks.
Secondary Outcome Measure Information:
Title
Myoelectrical activity.
Description
Soles, Tibialis Anterior and Peroneus Longus (myoelectrical activity in microvolts).
Time Frame
6 weeks.
Title
Jump Performance
Description
Countermovement Jump Test and Abalakov´s Test (jump height in cm).
Time Frame
6 weeks.
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification.
Between 9 and 16 years of age.
Ability to cooperate with simple instructions.
Able to stand for at least 2 min without assistance.
Able to walk at least 10 m without assistance.
Exclusion Criteria:
Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising
or if they did not meet the eligibility criteria.
12. IPD Sharing Statement
Learn more about this trial
Spastic Cerebral Palsy and Slackline
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